Cambium receives orphan drug designation for ocular graft-versus-host disease dry eye treatment
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The FDA has granted orphan drug designation to Cambium Medical Technologies’ fibrinogen-depleted human platelet lysate for the treatment of ocular graft-versus-host disease, according to a press release.
Elate Ocular is currently in phase 1/2 trials for the treatment of dry eye secondary to ocular graft-versus-host disease. The designation will provide benefits and incentives for development and commercialization for Elate as a promising treatment for a rare disease.
“We are honored to be awarded orphan drug status. It is another key milestone in the development of our Elate Ocular biologic,” Terry Walts, president and CEO of Cambium, said in the release. “As recently announced about the enrollment of the final patient in our phase 1/2 dry eye study, we selected oGvHD because of the need, because there is no approved therapeutic to date and finally to assess our biologic among a very severe patient population as a statement of its potential going forward.”